Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis

Hisun Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Cholestasis; Hepatitis B

Treatments: Drug: Ademetionine 3; Drug: Ademetionine 1; Drug: Ademetionine 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01998620

XMX-HBV-001

Details and patient eligibility

About

This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.

Full description

evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. from 18-65 years old
2. diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+)
3. with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP>1.5ULN and GGT>3ULN or STB>2ULN

Exclusion criteria

1. liver mass, liver carcinoma
2. liver failure
3. non-hepatic diseases caused jaundice
4. obstructive jaundice

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Ademetionine 1

Experimental group

Description:

Ademetionine 2000mg

Treatment:

Drug: Ademetionine 1

Ademetionine 2

Experimental group

Description:

Ademetionine 1000mg

Treatment:

Drug: Ademetionine 2

Ademetionine 3

Active Comparator group

Description:

no treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks

Treatment:

Drug: Ademetionine 3